Develop and implement pioneering cell based approaches to solving complex biological problems e.g. mechanistic biology, the use of iPSC and myocytes; development of novel assays; phenotypic screening paradigms.
Work with discovery teams to evaluate synthetic routes and test alternatives that facilitate scale up of both target compounds and building blocks while providing insights for selection of development candidates.
Design protein constructs that enable lab-scale interrogation of different mechanisms for modulating contraction and relaxation, working with external contract labs and internal staff to ensure suitable purity and homogeneity.
Identify and escalate significant compliance issues to relevant leadership, including the assessment of serious breaches; support Inspection Readiness program and make recommendations for its continuous.
Oversight of contract research organizations (CROs) for analytical method development & validation, release testing and stability activities; perform analytical characterization on drug substance and dose formulations in support of early discovery.
Oversees investigative sites' adherence to regulations through review of monitoring reports, QA-GCP audit reports and communications with investigators, study site personnel and Clinical Research Organization (CRO) team members.
The Manager, Clinical Operations plans and manages clinical projects while adhering to budget, scope and schedule requirements; participate in cross functional project teams representing clinical operations from primarily from a tactical perspective.
Participate in recruiting efforts by working with the HR department and external agencies on scheduling of interviews, coordination of interview packets, hosting of candidate(s) and on-boarding procedures of new team members.